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Oral Systemic Therapy- Adverse Drug Reaction Management Guide ANASTROZOLE Most patients treated with Anastrozole will experience adverse effects, but the effects will differ from one patient to the next. ADVERSE DRUG REACTION MANAGEMENT GUIDE 1. Hot flashes and flushing 9. 2. 10. Hair Loss (Alopecia) 3. 11. Pruritis 4. Anorexia 12. Rash 5. Xerostomia (Dry Mouth) 13. Pain problems 6. & 14. Fatigue & weakness 7. Dyspepsia 15. Osteoporosis 8. Insomnia

1. Hot flashes and flushing Hot flashes (or hot flushes) are waves of heat sensation which may occur without warning, similar to the hot flashes from female menopause. Flushing is a reddening of the skin, often accompanied by a feeling of heat. It is caused by local vasodilation. Hot flashes and flushing can be very troublesome for many patients. Prevention: Advise the patient to: • Keep room temperature lower, if possible • Dress in layers, so layers can be removed if hot flushes become uncomfortable • Natural health products may be tried, such as black cohosh, phytoestrogen supplements, evening primrose oil, dong quai, or ginseng. Evidence of benefit is lacking for most of these products. Watch for potential drug-drug interactions with the herbal product before advising use. • Accupuncture has been tried for relief of hot flushes, but there is no evidence of effectiveness • Psychoeducational interventions, as sometimes offered by psychosocial support teams in the cancer centres, may help patients to find ways to improve these symptoms Management: • Try systemic treatment with , , paroxetine or gabapentin (prescription); evidence of benefit is minimal, and drug side effects may limit use for some patients.

2. Diarrhea Diarrhea is very common in patients treated with Anastrozole. Dietary modifications are not recommended in anticipation of diarrhea, but must be considered if diarrhea occurs. Management: For mild diarrhea (less than 4 loose stools per day) • Follow instructions on loperamide (e.g., Imodium®) package insert: 2 tablets immediately, then 1 tablet after each liquid bowel movement (maximum: 8 tablets/24 hours) For moderate diarrhea (more than 4 to 6 loose stools per day or night-time diarrhea), tell the patient to be more aggressive with loperamide (e.g., Imodium®) for early-onset diarrhea • Take 2 tablets immediately, then 1 tablet every 2 hours during the day and 2 tablets every 4 hours during the night until bowel movements are normal for at least 12 hours

Revision Date: 04/14 ANASTROZOLE- Adverse Drug Reaction Management Guide

• This dosage is higher than packaging recommendations. Replace lost fluids: Fluid intake is more important than eating in patients with diarrhea. To replace lost fluid, advise patients to increase fluids by up to 3 to 4 litres per day (unless there is a known contraindication to increased fluid intake). The patient may drink several types of fluid, including plain water and electrolyte-containing drinks, such as clear broth, gelatin desserts, sports drinks, flat soft drinks, or decaffeinated tea Anal care: Recommend to your patient to: • Clean the anal area with mild soap and warm water after each bowel movement to prevent irritation • Apply a barrier cream or ointment, such as petroleum jelly or Isle’s paste • Soak in a warm bathtub or sitz bath to relieve discomfort Dietary changes during diarrhea: Advise your patients to change their diet while diarrhea is a problem: • Eat and drink small quantities of food often • Avoid spicy, greasy, or fried foods • Follow the BRAT (banana, rice, applesauce, toast) diet, along with clear liquids, until diarrhea begins to resolve • Follow a lactose-free diet • Avoid cabbage, brussel spouts, and broccoli, which may produce stomach gas, and cramps

3. Constipation Constipation is generally understood to be a reduction in bowel movements to fewer than 3 per week, or unsatisfactory (e.g. incomplete) . Reduced bowel function may give the misperception of constipation to patients who expect one or more movements daily. Constipation may be caused by this medication, other medications being taken concurrently (e.g. narcotic analgesics), or by the underlying cancer. Reduced physical activity or dietary changes, possibly related to this medication or the overall cancer treatment, may contribute to constipation. is often associated with constipation, but if symptoms become severe a medical assessment to examine for fecal impaction or bowel obstruction may be needed. Prevention: Advise patient to: • Change diet, if possible, to include more fruits, vegetables, and high-fibre foods. If the patient is taking a low-calorie diet, consider increasing calories to improve colonic transit. • Use of a regular laxative regimen, such as senna or bisacodyl at bedtime • Consider a bowel routine to maintain regularity, such as attempting bowel movements each morning after breakfast (usually the optimal time for a movement), using the toilet when there is an urge instead of repressing it, placing a footstool in front of the toilet to elevate thighs during movement. • Consider adding light exercise for patients with mostly sedentary lifestyles • Weight loss in over-weight patients may help improve bowel function Management: • If prophylactive stimulant laxative is not effective, try osmotic laxative (e.g. lactulose or PEG) • Stool softeners have not been shown to be effective • Drink of fluids

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• Biofeedback and relaxation techniques may help some patients with pelvic floor dysfunction. Psychosocial teams in the cancer centres may help with this type of intervention.

4. Anorexia Some patients on Anastrozole will lose weight and have decreased appetite. It is important to try and maintain weight, if possible, to improve well-being and to better control the cancer. Use of nutrition supplements (e.g. Boost®, Ensure®) on top of tolerated diet may help maintain optimal body weight. Management: The following may provide additional help with anorexia: • There are no medications that have demonstrated an effect to relieve fatigue • Mild exercise is very helpful to reduce fatigue, but must be manageable if there is also muscle weakness

5. Xerostomia (Dry Mouth) Patients may experience xerostomia (dry mouth). This condition is characterized by a dry, tough tongue; cracks in lips and at corners of mouth; pain or burning in mouth or on tongue; sticky, dry mouth; and thick, stringy . This may cause patients to have trouble speaking or swallowing, a constant sore throat, hoarseness, and dry nasal passages that may result in nosebleeds. Xerostomia can cause mouth sores, gum , and tooth loss. is also associated with xerostomia. Prevention: Advise patients to: • Check their mouth daily for red, white, or dark patches; sores or sign of • Chew sugarless gum or candies to increase saliva flow • Avoid or dental products containing alcohol • Use a cool-mist humidifier (especially at night) • Sip water throughout the day or suck on ice chips • Drink 8 cups of water daily; eat soft, moist food; avoid alcohol, caffeinated beverages, and spicy, sugary, or acidic foods • Avoid smoking Management: There are several OTC treatments to address xerostomia: • Artificial saliva (e.g. Biotène®, Moi-Stir®, Mouth Kote®) • Meticulous o Brush teeth 2-4 times daily with a soft bristle toothbrush. Soak toothbrush in warm water to soften bristles. o Floss gently once daily to avoid gum injury o Salt and baking soda rinses (1/2 tsp of each ingredient in 1 cup of warm water at least 4 times daily, especially after meals) o Use a low-abrasive fluoride o Avoid products that contain sodium lauryl sulfate, which may worsen canker sores o Orajel®, Vaseline®, or glycerine swabs to relieve dryness and cracks on lips and under Prescribed medications such as fluoride gel (dentist) and (or other drugs that increase saliva production).

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6. Nausea & vomiting Nausea and vomiting may occur in up to 30% of patients on Anastrozole. Unlike the nausea and vomiting often experienced by patients on cytotoxic (acute onset, more emesis than nausea), patients on Anastrozole tend to have nausea of lesser severity and longer duration, with or without emesis. This can be more distressing to patients’ quality of life than acute nausea and vomiting. Often patients will have nausea without the relief that comes from emesis.

Management: The following may provide relief from nausea and vomiting: • Prophylactic agents (e.g. dopaminergic agents such as prochlorperazine, or promotility agents such as metoclopramide) given with each dose of Dasatinib and repeated as needed for nausea control. While there is no evidence to support the use of dimenhydrinate, there is evidence that ginger products (e.g. Gravol® Ginger) may be effective, with fewer adverse effects • Avoid spicy or greasy foods that may contribute to the feeling of nausea. Bland foods, fresh air, and plenty of clear water may reduce the feelings of nausea

7. Dyspepsia Dyspepsia, or acidic stomach, may be a temporary or chronic problem for some patients. It generally presents as upper abdominal pain, postprandial fullness or early satiety. Dyspepsia occurs in 25% of people, so it may be hard to tell if it is caused by the drug. It may or may not lead to peptic ulcers, but is not usually accompanied by . Management is often symptomatic and as needed. Prevention: Advise patients to: • Avoid foods that cause stomach upset (e.g. spicy foods) • Avoid lying down after meals • Reduce alcohol and/or caffeine intake • Eat smaller meals more frequently • Reduce stress from daily life Management: There are several OTC and prescription treatments to address dyspepsia: • Antacids (aluminum hydroxide, calcium carbonate, magnesium salts, combinations with or without simethicone for gas) • Histamine type 2 receptor antagonists (e.g. ranitindine, famotidine) • Proton pump inhibitors (e.g. omeprazole, esomeprazole, pantoprazole, )

8. Insomnia Insomnia, or the inability to fall asleep and/or stay asleep, may be a symptom of depression, a drug side effect, a reaction to unresolved pain, or a natural reaction to daily stress and worries (e.g. about the cancer). Many drugs can contribute to insomnia problems. Prevention: Advise patients to: • Avoid alcohol, nicotine (e.g. smoking, nicotine supplements) and caffeine intake, especially in the evening • Avoid large meals late in the evening • Use earplugs and/or eye masks if helpful. Turn the clock face away from sight and use the alarm daily. • Try relaxation exercises

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• Maintain a regular pattern of timing for going to bed and rising, 7 days a week. Limit mid-day naps. Do not sleep in on weekends or free days. • Regular aerobic exercise (e.g. walking) during the day can help stimulate the need for sleep at night. Exercise should be enough to cause sweating, with a duration of 30 to 40 minutes daily. Do not overexert if there are other physical limitations to exercise Management: There are many medications (prescription and OTC) used for insomnia. Try to start with the least potent options and limit use to short periods if possible. • Common OTC products contain or . These products may help patients to fall asleep. • Natural health products have limited evidence of effectiveness, but are often used. Products may contain Valerian or Melaton. • Prescription hypnosedatives may be considered. Options include benzodiazepines (e.g. lorazepan, flurazepam) and non-benzodiazepines (e.g. zopiclone).

9. Fever Fever, or increased body temperature, may occur with this drug. While fever is uncomfortable, be careful if the patient is at risk of febrile neutropenia from the drug. Reducing fever can mask the symptoms of emergent infection and cause a delay in management of this potentially life-threatening problem. Management: The following may provide relief from headaches and other general pain problems: • Non-pharmacologic approaches, such as a sponge bath with tepid water, or a cool cloth on the forehead, may provide some relief from fever • Antipyretics- Acetaminophen preferred; do NOT use non-steroidal anti-inflammatory agents, prescription or OTC due to risk of (e.g. ibuprofen, ASA, naproxen), unless your doctor tells you these drugs are OK to use.

10. Hair Loss (Alopecia) Between 10 and 65% of patients will have hair loss while taking Etoposide. Most patients will loss a minimal amount of hair on the oral form of this agent. Prevention: • Although there is no way to prevent hair loss, you may advise the patient that hair will usually regrow, once the treatments are over. The replacement hair may have a different colour or consistency. Management: • If hair loss bothers the patient, a wig, hat, cap, scarf or hair piece may be worn

11. Pruritis Pruritis (itchiness) may occur when taking Anastrozole, and usually happens because skin has lost its moisture. Prevention: Preventing dry skin is the key to preventing pruritus. Advise your patients to: • Use mild soaps that are deodorant and fragrance-free (e.g. Dove® or Neutrogena®) • Apply lotions or bland emollients (Eucerin® cream, Neutrogena® Norwegian Formula Hand Cream, Vaseline Intensive Care® Advanced Healing Lotion) often.

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• Use liquid shower gels in place of soap. Management: For mild-moderate Pruritus, consider advising patients to: • Apply more lotion that usual to help eliminate itchiness. • Use lotions that contain aloe vera or dimethicone Moisturel® • Use antidandruff shampoo and conditioner • Use hair products that contain tea tree oil, which contain extra moisturizers and may help with symptoms

12. Rash Rash is a common adverse effect of Anastrozole. Rash symptoms often appear soon after starting treatment. This rash presents with spots and bumps on the forearms, trunk, and sometimes, the face. They are often itchy, but if scratched, may become infected and crusty. Most cases of this generalized skin rash are mild and go away on their own. Rash is more common in women and patients on higher doses, and may worsen after sun exposure. It is important to recognize rash symptoms early and start symptomatic therapy promptly.

Prevention: Prevention should begin when Anastrozole therapy is begun, and continue throughout treatment. You should advise your patient to: • Cleanse with mild soaps or cleaners or bath or shower oils to avoid skin dryness • Moisturize twice a day with thick, emollient-based creams, such as Aveeno® lotion, Neutrogena® Norwegian Formula hand cream, or Vaseline Intensive Care® Advanced Healing Lotion • Use only fragrance- , alcohol-, and dye-free lotions and cosmetics • Use a dermatologist-approved cover-up, such as Dermablend® or Cover FX® • Remove make-up with a gentle, skin-friendly cleanser (e.g., Neutrogena®, Dove®). • Use a broad-spectrum sunscreen (SPF of 30 or more) that contains zinc oxide or titanium dioxide Management: For Mild to moderate skin rash, there are some over-the-counter options you may consider: • (diphenhydramine) • Topical steroid (hydrocortisone 0.5%) • Coal tar preparations If the rash progresses to moderate to severe, the patient may need prescribed therapy: • Oral corticosteroids (short course, with or without topical triamcinolone acetonide 0.1% ointment) • Temporary interruption of therapy until the rash resolves, and then re-challenge at low dose

13. Pain problems Patients on Anastrozole may experience headaches, back pain, and/or joint pain, or other types of body aches and pains. Management: The following may provide relief from headaches and other general pain problems:

• Mild pain may respond to non-pharmacologic approaches, such as rest, distraction, cool cloth on the forehead • Mild pain medications- Acetaminophen preferred; do NOT use non-steroidal anti-inflammatory agents, prescription or OTC due to risk of bleeding (e.g. ibuprofen, ASA, naproxen)

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• Acetaminophen with , either OTC (low dose) or on prescription (higher dose) may be considered for more severe pain. • For bone or joint pain, consider the use of heating pads, ice packs, or topical arthritis creams and liniments • Mild exercise and/or massage therapy may help reduce bone and joint pain If there is a neuropathic component to the pain, consider a trial with a tricyclic (e.g. low dose amitriptyline or ) or gabapentin • If acetaminophen is not sufficient to control pain, consider prescription analgesics for management of more severe pain (possibly due to tumor) • Mild exercise and/or massage therapy may help reduce bone and joint pain

14. Fatigue & weakness Some patients on anastrozole will experience fatigue and asthenia (or general weakness). These symptoms are not life-threatening but will significantly reduce quality of life. Management: The following may provide relief from fatigue: • There are no medications that have demonstrated an effect to relieve fatigue • Mild exercise is very helpful to reduce fatigue

15. Osteoporosis Osteoporosis is the loss of bone mineral density, resulting in skeletal fragility. It affects 1 in 4 women and 1 in 8 men, increasing in older adults. The more the bones thin out, the greater the risk of fracture. Osteoporosis may be increased with some medications. Prevention: • Take 1000 mg calcium and at least 400U (10 mcg) Vitamin D supplement daily. This is available OTC. • Add weight-bearing exercise (e.g. walking, jogging) to daily activities. Management: • Prescription bisphosphonate therapy (e.g. alendronate, etidronate, risedronate) may be added to calcium and vitamin D.

REFERENCES: ONTarget Resource Guide, Common Side Effects from Targeted Therapy. The Groupe d’étude en oncologie and The Canadian Association of Pharmacy in Oncology, 2012. Systemic Therapy Manual for Cancer Treatment, Cancer Care Nova Scotia, 2013 Patient Self-Care. Helping Your Patients Make Therapeutic Choices. Canadian Pharmaceutical Association , 2010 Therapeutic Choices, Sixth Edition, Canadian Pharmaceutical Association , 2011

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